Systems and methods using annotated images for controlling the use of diagnostic or therapeutic instruments in instruments in interior body regions

ABSTRACT

An interface, used in association with an electrode structure deployed in contact with heart tissue, generates a display comprising an image of the electrode structure at least partially while performing a therapeutic or diagnostic procedure. The interface annotates the image in response to procedure events.

BACKGROUND OF THE INVENTION

This invention relates generally to systems for diagnosing and treatingmedical conditions using instruments deployed within a living body.

FIELD OF THE INVENTION

Multiple electrode arrays are used to diagnose or treat a variety ofmedical conditions.

For example, physicians use arrays of multiple electrodes to examine thepropagation of electrical impulses in heart tissue to locate aberrantconductive pathways. The techniques used to analyze these pathways,commonly called "mapping," identify regions in the heart tissue, calledfoci, which can be ablated to treat the arrhythmia. When used for thispurpose, the multiple electrode arrays are typically located inelectrical contact with either epicardial or endocardial tissue. Themultiple electrodes are coupled to an external cardiac stimulator, whichapplies electrical pacing signals through one or more electrodes atgiven frequencies, durations, or amplitudes to myocardial tissue, aprocess called "pacing." The multiple electrodes on the array are alsotypically coupled to signal processing equipment, called "recorders,"which display the morphologies of the electrocardiograms or electrogramsrecorded during pacing. Sometimes, another roving electrode is deployedin association with the multiple electrode array, to pace the heart atvarious endocardial locations, a technique called "pace mapping." Whenit is desired to ablate myocardial tissue, an electrode coupled to asource of, e.g., radio frequency energy is deployed.

In conducting these diagnostic or therapeutic procedures, the physicianmust compare all paced electrocardiograms or electrograms to thosepreviously recorded during an induced arrhythmia episode. The physicianalso must know the position of all deployed electrodes in order tointerpret the data in a meaningful way. The physician also needs to beable to accurately maneuver and position the roving or ablationelectrode, when used. For these reasons, these procedures required aconsiderable degree of skill and experience on the part of the attendingmedical personnel.

Conventional systems and methods designed to aid the physician in hisdifficult task became impractical and unwieldy as new technologyprovides more sophisticated arrays, have more electrodes arranged withincreased density. With larger and more dense electrode arrays, thenumber of possible failure modes also increases. Conventional systemsand methods cannot automatically and continuously monitor the status ofthe more sophisticated arrays, to warn the physician in the event of anopened or shorted electrode condition or other malfunction.

Thus, there is a need for improved systems and methods for manipulatingand monitoring the use of multiple electrode arrays, as well as systemsand methods for processing, monitoring, and interpreting data frommultiple electrode arrays in an efficient, organized manner.

SUMMARY OF THE INVENTION

One aspect of the invention provides an interface for use in associationwith an electrode structure which, in use, is deployed in contact withheart tissue to perform a diagnostic or therapeutic procedure. Theinterface includes a controller coupled to the electrode structure,which conditions the electrode structure to perform a diagnostic ortherapeutic procedure and to monitor events during the procedure. Theinterface also includes a display screen and an interface managercoupled to controller and the display screen. The interface managerincludes a first function to generate a display comprising an image ofthe electrode structure at least partially while performing theprocedure. The interface manager also includes a second function toannotate the image in response to events monitored by the controller.

Another aspect of the invention provides a method for mapping myocardialtissue. The method deploys an electrode structure in contact withmyocardial tissue. The method generates a display comprising an image ofthe electrode structure. The method causes the electrode structure topace myocardial tissue and record paced electric events in myocardialtissue while the image is displayed for viewing. The method annotatesthe image in response to the paced electrical events which are recorded.

Another aspect of the invention provides systems and methods forexamining myocardial tissue. The systems and methods deploy an electrodestructure in contact with myocardial tissue. The systems and methodsgenerate a display comprising an image of the electrode structure. Thesystems and methods annotate the image to show an anatomic feature. Thesystems and methods cause the electrode structure to conduct adiagnostic or therapeutic procedure affecting myocardial tissue whilethe image is displayed for viewing.

Other features and advantages of the inventions are set forth in thefollowing Description and Drawings, as well as in the appended Claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a system, which couples severalindividually controlled diagnostic or therapeutic instruments to a mainprocessing unit through an instrument interface and which includes agraphical user interface (GUI);

FIG. 2 is a schematic view of the representative instruments, includinga multiple electrode basket, a roving electrode, and a roving imagingdevice, which are coupled to individual controllers via the instrumentinterface;

FIG. 3 is a schematic view of the instrument interface;

FIG. 4 is a depiction of the start-up screen of the GUI;

FIG. 5 is a depiction of the record protocols-configuration screen ofthe GUI;

FIG. 6 is a depiction of the record protocols-sequence screen of theGUI;

FIG. 7 is a depiction of the pace protocols-configuration screen of theGUI;

FIG. 8 is a depiction of the pace protocols-sequence screen of the GUI;

FIG. 9 is a depiction of the virtual image navigation screen of the GUI;

FIG. 10 is an enlarged view of the idealized image of the multipleelectrode basket displayed by the virtual image navigation screen of theGUI;

FIG. 11 is a depiction of the virtual image navigation screen of theGUI, with the Binary Map dialog box displayed;

FIG. 12 is a depiction of the binary map dialog box with the Create Mapcontrol button selected;

FIG. 13 is a depiction of the virtual image navigation screen of theGUI, with the Anatomic Features dialog boxes displayed;

FIG. 14 is a schematic view showing the creation of proximity-indicatingoutput for display by the virtual image navigation screen of the GUI;

FIG. 15 is an enlarged view of an idealized image displayed by thevirtual image navigation screen of the GUI, with the Sensitivity Adjdialog box displayed for adjusting sensitivity of theproximity-indicating output;

FIG. 16 is an enlarged view of an idealized image displayed by thevirtual image navigation screen of the GUI, showing the interpolation ofproximity-indicating output;

FIG. 17 is a schematic view showing the creation of location outputbased upon spacial variations in electrical potentials, for display bythe virtual image navigation screen of the GUI;

FIG. 18 is a schematic view showing the creation of location outputbased upon differential waveform analysis, for display by the virtualimage navigation screen of the GUI;

FIG. 19 is a depiction of the virtual image navigation screen of theGUI, with the Markers dialog box displayed;

FIG. 20 is a depiction of the virtual image navigation screen of theGUI, with the Find Site dialog box displayed;

FIG. 21 is a depiction of the real image navigation screen of the GUI;

FIG. 22 is a depiction of the real image navigation screen of the GUI,with the compare image function enabled;

FIG. 23 is a schematic showing an implementation of the analyze imagefunction;

FIG. 24 is a depiction of the test screen of the GUI;

FIG. 25 is a depiction of the print screen of the GUI;

FIG. 26 is a depiction of the service screen of the GUI;

FIG. 27 is a depiction of the virtual image navigation screen of theGUI, with the Event Log control button function toggled on to displaythe Event Log;

FIG. 28 is a depiction of the virtual image navigation screen of theGUI, with the Patient Data Base function enabled and the Patient Datadialog box opened for data input at the outset of a new study;

FIG. 29 is a depiction of the virtual image navigation screen of theGUI, with the Patient Data Base function enabled and the Select Imagedialog box opened for data input;

FIG. 30 is a depiction of the print screen of the GUI, with the PatientData Base control button selected to open the Patient Records dialogbox;

FIG. 31 is a depiction of the print screen of the GUI, with the PatientData Base control button selected and the Directory dialog box opened;and

FIG. 32 is a depiction of the print screen of the GUI, with the PatientData Base control button selected and the Find/Sort dialog box opened.

The invention may be embodied in several forms without departing fromits spirit or essential characteristics. The scope of the invention isdefined in the appended claims, rather than in the specific descriptionpreceding them. All embodiments that fall within the meaning and rangeof equivalency of the claims are therefore intended to be embraced bythe claims.

DESCRIPTION OF THE PREFERRED EMBODIMENTS I. System Overview

FIG. 1 shows a system 10 for diagnosing, treating or otherwiseadministering health care to a patient.

The system 10 includes various diagnostic or therapeutic instruments.For the purpose of illustration, FIG. 1 shows three instruments 12, 14,and 16.

In the illustrated embodiment, the instrument 12 comprises an array ofmultiple electrodes 18. In the illustrated embodiment, the instruments14 and 16 each comprises an operative element usable for some diagnosticor therapeutic purpose.

For example, one of the operative elements 14 or 16 can comprise adevice for imaging body tissue, such as an ultrasound transducer or anarray of ultrasound transducers, or an optic fiber element, or a CT orMRI scanner. Alternatively, one of the operative elements 14 or 16 cancomprise a device to deliver a drug or therapeutic material to bodytissue. Still alternatively, one of the operative elements 14 or 16 cancomprise a device, e.g., an electrode, for sensing a physiologicalcharacteristic in tissue, such as electrical activity in heart tissue,or for transmitting energy to stimulate or ablate tissue.

When deployed in the body, the operative elements 14 and 16 can bereadily moved relative to the multiple electrode array 12. For thisreason, the instruments 14 and 16 will also each sometimes be called a"roving instrument."

The system 10 includes one or more instrument controllers (designated20, 22, and 24). In use, the controllers 20, 22, and 24 condition anassociated instrument 12, 14, and 16 to perform its desired diagnosticor therapeutic functions. The functions depend upon the medicalobjectives of the system 10. Representative specific examples will bedescribed later.

To aid in coordinating signal and data flow among the controllers 20,22, and 24 and their linked instruments, the system 10 includes aninstrument manager or interface 26. The interface 26 couples theinstrument controllers 20, 22, and 24 to their respective instruments12, 14, and 16, establishing electrical flow paths, which process thevarious diagnostic or therapeutic data and signals in an organized andefficient fashion. Generally speaking, the interface 26 serves as amaster switching unit, which governs the connections linking theinstrument controllers 20, 22, and 24 to the individual instruments 12,14, and 16.

The interface 26 can comprise an integrated module, or an assembly ofdiscrete components. Further details of a representative embodiment forthe interface 26 will described later.

The system 10 also includes a main processing unit (MPU) 28. In theillustrated embodiment, the MPU 28 comprises a Pentium™ typemicroprocessor, although other types of conventional microprocessors canbe used.

The MPU 28 includes an input/output (I/O) device 30, which controls andmonitors signal and data flow to and from the MPU 30. The I/O device 30can comprise, e.g., one or more parallel port links and one or moreconventional serial RS-232C port links or Ethernet™ communication links.

The I/O device 30 is coupled to a data storage module or hard drive 32,as well as to the instrument interface 26 and a printer 34.

The system 10 also includes an operator interface module 36, which iscoupled to the I/O device 30. In the illustrated embodiment, theoperator interface 36 includes a graphics display monitor 38, a keyboardinput 40, and a pointing input device 42, such as a mouse or trackball.The graphics display monitor 38 can also provide for touch screen input.

The system 10 includes an operating system 44 for the MPU 28. In theillustrated embodiment, the operating system 44 resides as processsoftware on the hard drive 32, which is down loaded to the MPU 28 duringsystem initialization and startup. For example, the operating system 44can comprise a Microsoft WINDOWS® 3.1, WINDOWS 95® or NT operatingsystem. Alternatively, the operating system 44 can reside as processsoftware in EPROM's in the MPU 28.

In the illustrated embodiment, the operating system 44 executes throughthe operator interface 36 a graphical user interface, or GUI 46, thedetails of which will be described later. Preferably, the GUI 46 isconfigured to operate on a WINDOWS® compatible laptop or desktopcomputer. The GUI 46 can be realized, e.g., as a "C" language programimplemented using the MS WINDOWS™ application and the standard WINDOWS32 API controls, e.g., as provided by the WINDOWS™ Development Kit,along with conventional graphics software disclosed in publicliterature.

The MPU 28, hard drive 32, and the components of the operator interface36 can be implemented in a conventional lap top or desktop computer,which serves as a host for the operating system 44 and GUI 46. Othercomputer system forms can, of course, be used, e.g., using a server tohost the operating system 44 and GUI 46 for a network of workstations,each of which comprises an operator interface 36.

In whatever form, the operating system 44 administers the activation ofa library 48 of control applications, which are designated, for purposeof illustration, as A1 to A7 in FIG. 1. In the illustrated embodiment,the control applications A1 to A7 all reside in storage 54 as processsoftware on the hard drive 32 and are down loaded and run based uponoperator input through the GUI 46. Alternatively, all or some of thecontrol applications A1 to A7 can reside as process software in EPROM'sin the MPU 28, which can likewise be called and run through the GUI 46.

Each control application A1 to A7 prescribes procedures for carrying outgiven functional tasks using the system 10 in a predetermined way. Ofcourse, the number and functions of the applications A1 to A7 can vary.

In the illustrated and preferred embodiment, the library 48 includes oneor more clinical procedure applications, which are designated A1 and A2in FIG. 1. Each procedure application A1 and A2 contains the steps tocarry out a prescribed clinical procedure using the system 10. When runby the operating system 44, each procedure application A1 and A2generates prescribed command signals, which the I/O device 30distributes via the instrument interface 26 to condition the instrumentcontrollers 20, 22, and 24 to perform a desired task using theinstruments 12, 14, and 16. The I/O device 26 also receives data fromthe instrument controllers 20, 22, and 24 via the instrument interface26 for processing by procedure application A1 or A2 being run. The GUI46 presents to the operator, in a graphical format, various outputsgenerated by the procedure application A1 or A2 run by the operatingsystem 44 and allows the user to alter or modify specified processingparameters in real time. Further details of specific representativeprocedure applications A1 and A2 will be described in greater detaillater.

In the illustrated and preferred embodiment, the library 48 alsoincludes one or more specialized navigation applications A3 and A4. Thenavigation applications A3 and A4, when run by the operating system 44,allow the operator to visualize on the GUI 46 the orientation of themultiple electrode array 12 and roving instruments 14 and 16 whendeployed in an interior body region. The navigation applications A3 andA4 thereby assist the operator in manipulating and positioning theseinstruments to achieve the diagnostic or therapeutic results desired. Inthe illustrated embodiment, one navigation application A3 constructs anideal or virtual image of the deployed array 12 and the rovinginstruments 14, and 16, while the other navigation application A4displays an actual, real-time image of these instruments 12, 14, and 16.One or both of the navigation applications A3 and A4 can also display ingraphical form on the GUI 44 information to aid the operator ininterpreting data acquired by the multiple electrode array 12 and rovinginstruments 14 and 16 when deployed in an interior body region.

In the illustrated and preferred embodiment, the library 48 alsoincludes one or more utility applications A5 to A7. The utilityapplications A5 to A7 carry out, e.g., system testing, system servicing,printing, and other system support functions affecting the allapplications. Further details of representative utility applications A5to A7 will be described in greater detail later.

The operating system 44 also includes one or more speciality functions(designated F1 and F2 in FIG. 1), which run in the background duringexecution of the various applications A1 to A7. For example, onefunction F1 can serve to establish and maintain an event log 50, storedin the hard drive 32, which keeps time track of specified importantsystem events as they occur during the course of a procedure. Anotherfunction F2 can serve to enable the operator, using the GUI 44, to download patient specific information generated by the various applicationsA1 to A7 to the hard drive 32 as data base items, for storage,processing, and retrieval, thereby making possible the establishment andmaintenance of a patient data base 52 for the system 10.

As described, the system 10 is well adapted for use inside body lumens,chambers or cavities for either diagnostic or therapeutic purposes. Forthis reason, the system 10 will be described in the context of its usewithin a living body.

The system 10 particularly lends itself to catheter-based procedures,where access to the interior body region is obtained, for example,through the vascular system or alimentary canal. Nevertheless, thesystem 10 can also be used in association with systems and methods thatare not necessarily catheter-based, e.g., laser delivery devices,atherectomy devices, transmyocardial revascularization (TMR),percutaneous myocardial revascularization (PMR), or hand held surgicaltools.

For example, the system 10 can be used during the diagnosis andtreatment of arrhythmia conditions within the heart, such as ventriculartachycardia or atrial fibrillation. The system 10 also can be usedduring the diagnosis or treatment of intravascular ailments, inassociation, for example, with angioplasty or atherectomy techniques.The system 10 also can be used during the diagnosis or treatment ofailments in the gastrointestinal tract, the prostrate, brain, gallbladder, uterus, and other regions of the body.

For the purpose of illustration, representative components of the system10 will be described in the context of the diagnosis and treatment ofabnormal cardiac conditions. In this environment, the multiple electrodearray 12 and roving instruments 14 and 16 are deployable within or neara heart chamber, typically in one of the ventricles.

A. Operating Instruments

The structure of the array of multiple electrodes 18 carried by thefirst instrument 12 can vary. In the illustrated embodiment (see FIG.2), the instrument 12 comprises a composite, three-dimensional basketstructure 58 that is carried at the distal end of a catheter tube 56 forintroduction into the targeted heart chamber. The basket structureincludes eight spaced apart spline elements (alphabetically designated Ato H in FIG. 2) assembled together by a distal hub 60 and a proximalbase 62. Each spline A to H, in turn, carries eight electrodes 18, whichare numerically designated on each spline from the most proximal to themost distal electrode as 1 to 8 in FIG. 2. The basket structure 58 thussupports a total of sixty-four electrodes 18, which FIG. 2 identifiesalpha-numerically by spline and electrode order, e.g., (A,8), whichidentifies the most distal electrode on spline A. Of course, a greateror lesser number of spline elements and/or electrodes 18 can be present.

Each spline element A to H preferably comprises a flexible body madefrom resilient, inert wire or plastic. Elastic memory material such asnickel titanium (commercially available as NITINOL™ material) can beused. Resilient injection molded plastic or stainless steel can also beused. Each spline element A to H is preferably preformed with a convexbias, creating a normally open three-dimensional basket structure.

The basket structure 58 is deployed in the heart by advancement througha conventional guide sheath (not shown) snaked through the vasculature.The guide sheath compresses and collapses the structure 58. Retractionof the guide sheath allows the structure 58 to spring open into thethree-dimensional shape shown in FIG. 2. Further details of thestructure and deployment of the multiple electrode structure can befound in U.S. Pat. No. 5,647,870, which is incorporated herein byreference.

Each of the electrodes 18 is electrically connected to an individualconductor in a multiple conductor cable 64 (see FIG. 1 also). The cable64 terminates in one or more connectors, through which electricalconnection can be made to the individual conductors and, hence, to theindividual electrodes. The connectors are coupled to the instrumentinterface 26.

The instrument 12 need not be configured as a basket 58. For example,the array can take the form of an elongated electrode array, which canbe straight, curved, or formed into a loop. For another example, athree-dimensional structure can be formed carrying dual outer and innerarrays of electrodes. Various other configurations for multipleelectrode arrays are shown in copending U.S. patent application Ser. No.08/938,721, filed Sep. 26, 1997, and entitled "Systems and Methods forGenerating Images of Structures Deployed Within Interior Body Regions."

In the illustrated embodiment (see FIG. 2), the first roving instrument14 is also carried at the distal end of a catheter tube 66 fordeployment and manipulation in the body. In the illustrated embodimentrepresentative for the system 10, the instrument 14 comprises anelectrode 68 intended, in use, to sense electrical activity in hearttissue, as well as to transmit energy to stimulate or ablate tissue. Theelectrode 68 is electrically connected by a cable 70 to the instrumentinterface 26.

The second roving instrument 16 comprises an imaging device 72. Theimaging device 72 operates using a selected visualizing technique, e.g.,fluoroscopy, ultrasound, CT, or MRI, to create a real-time image of abody region. A cable 76 conveys signals from the imaging device 72 tothe instrument interface 26.

B. Instrument Controllers

In the representative embodiment (see FIG. 2), the instrument controller20 comprises at least one external cardiac stimulator. The cardiacstimulator 20 hosts a selection of diagnostic procedures, whichgenerates electrical pulses of various duration, number, and cycles. Thepulses stimulate or pace myocardial tissue, so that resultant electricalactivity can be mapped.

A stimulator 20 of the type is of the type currently used inelectrophysiology labs and can be commercially purchased, e.g., fromMedtronic or Bloom, and. The system 10 can include additionalstimulators, if desired. When multiple stimulators are present, theinterface 26 can quickly switch between different pulse frequencies,durations, or amplitudes during pacing.

In the representative embodiment, the instrument controller 22 comprisesan electrogram recorder of the type that is commercially available from,e.g., Prucka, Quinton, E for M, Bard, and Siemens. The electrogramrecorder 22 functions to record, store, process, analyze, and displaysignals acquired by the electrodes on the basket structure 58 and aswell as the roving electrode 68 during pacing.

In the representative embodiment, the instrument controller 24 comprisesan appropriate controller for the imaging device 72. The controller 24generates a video output from the signals generated by the device 72.The format of the video output can vary, e.g., it can comprise compositevideo, video-modulate RF signal, or RGB/RGBI including applicable TVstandards (i.e. NTSC, PAL or SECAM).

As shown in FIG. 2, a generator for transmitting radio frequencyablation energy can also be coupled to the roving electrode 68, throughthe instrument interface 26 (as shown in solid lines in FIG. 2), orthrough its own instrument interface 26' (shown in phantom lines in FIG.2) coupled to the MPU 28.

C. The Instrument Interface

In the illustrated embodiment (see FIG. 3), the instrument interface 26is centered around an application specific integrated circuit (ASIC) 80of the type shown and described in U.S. application Ser. No. 08/770,971entitled, "Unified Switching System for Electrophysiological Stimulationand Signal Recording and Analysis," filed Dec. 12, 1996, which isincorporated herein by reference. Alternatively, as previously stated,the interface 26 can comprise an assembly of separate components and notan integrated circuit.

In the illustrated embodiment, the ASIC 80 comprises a cross pointswitch matrix 82. The matrix 82 includes a block of primary analog inputpins 84 through which low level external signals from the recorder 22and real image processor 24 can be received. A block of additionalanalog input pins 86 are provided, through which high level externalsignals, such as those produced by the stimulator 20 or generator 78,can be received. The matrix 82 includes a block of analog output pins88.

The matrix 82 enables any of the input pins 84/86 to be connected to anyof the output pins 88. This operation permits, for example, varioussubsets of the electrodes 18 on the basket structure 58 to be connectedto various subsets of input channels 116 of the electrogram recorder 22.In addition, any of the high level input pins 86 can be coupled to anyof the primary input pins 84. This permits pacing pulses generated bythe stimulator 20 to be applied through any of the electrodes 18 on thebasket structure 58 or through the roving electrode 68. Alternatively,high level pacing pulse signals can be switched backward from any of theoutput pins 88 to any of the input pins 84, to permit "retrograde"pacing from the electrogram recorder 22, if it has pacing outputcapabilities. The various instruments 12, 14, and 16 are coupled to theASIC 80 through appropriate isolation circuitry (not shown), whichisolates the ASIC 80 from potentially damaging signals, currents andvoltages.

The ASIC 80 includes embedded on-chip software that comprises a switchmanager 90. In response from high level commands from the MPU 28 (whichare generated by the selected application A1 to A7 or function F1 or F2run by the operating system 44 on the MPU 28), the switch manager 90configures the cross point switch matrix 82 to establish desiredelectrical connections among the various instruments 12, 14, and 16 andcontrollers 20, 22, and 24, to carry out various operating modes for thesystem 10.

The number and type of operating modes controlled by the switch manager90 in large part parallel the number and type of applications A1 to A7and functions F1 and F2 available for execution by the operating system44.

For example, when the procedure applications A1 and A2 are executed, theswitch manager 90 enters a procedure mode. In this mode, the manager 90configures the multiple electrodes 18 on the basket structure 58 and theroving electrode 68 for recording or pacing based upon the commandsignals generated by the MPU 28.

The procedure mode carried out by the switch manager 90 is notnecessarily constrained by the data channel limitations of theassociated instrument controllers. For example, if the procedureapplication A1 or A2 calls for signal acquisition or pacing fromsixty-four (64) electrodes, and the data acquisition capabilities of theelectrogram recorder 22 happens to be only twenty-four (24) channels116, the switch manager 90 configures the sixty-four (64) electrodesinto four subsets of sixteen (16) electrodes, switching among thesubsets to achieve the desired data acquisition task using the availablechannels 116 of the recorder 22. The interface 26 displays a visual PACEoutput, e.g., through a LED 92 on an exterior panel 114, which isactivated when the stimulator 20 is coupled by the manager 90 to one ormore instrument electrodes.

When the navigation application A3 or A4 is executed, the manager 90 iscommanded by the MPU 28 to enable the navigation mode. During thenavigation mode controlled by the virtual navigation application A3, themanager 90 periodically communicates to the MPU 28 the electricallysensed position of the roving electrode 68 for display in the GUI 46,using an embedded navigation routine 94, which will be described ingreater detail later. In a preferred embodiment, the position reportingfrequency is at least once per heart chamber cycle (i.e., once every 150ms or greater).

When the navigation mode is controlled by real image application A4, themanager 90 inputs signals from the imaging device 72 to the processor24, and outputs processed video signals to the MPU 28 for display on theGUI 46.

The interface displays visual NAVIGATION DISABLED and NAVIGATION ENABLEDoutputs, e.g., through LEDs 96 and 98 on the exterior panel 114. TheNAVIGATION ENABLED LED 98 is activated when either navigationapplication A3 or A4 is executed and the navigation mode is enabled.Conversely, the NAVIGATION DISABLED LED 96 is activated when neithernavigation application A3 or A4 are executed.

In an illustrated embodiment, the multiple electrode instrument 12carries an electrical identification code 100, which uniquely identifiesthe physical property and configuration of the electrodes on the basketstructure 58. The switch manager 90 includes an embedded ID routine 102,which electrically senses the code 100 and inputs configuration dataaccording to the code 100 for use in the navigation routine 94. The code100 can be variously implemented, e.g., in an integrated circuit, whichexpresses the code 100 in digital form, or as separate electricalelements, such as several resistors having different resistance valueswhich express the digits of the code 100.

In the illustrated embodiment, application A5 constitutes a prescribedtesting utility. When the testing application A5 is executed on the MPU28, the switch manager 90 responds to high level commands generated bythe application A4 to stop recording, pacing, and navigation switchingtasks, and configure the cross point switch matrix 82 to perform variousprescribed system tests, e.g., open or short-circuit detection andconfirmation of system connections. More details of these and otherutility applications A6 and A7 will be described later. The interfacedisplays a visual TEST output, e.g., through a LED 104 on the exteriorpanel 114, which is activated when the testing application A5 isexecuted.

In a preferred embodiment, the embedded on-chip switch manager 90 alsoruns a self-test routine 106 immediately after power-on or hardwarereset. In the self-test mode, the manager 90 verifies the overallfunctionality of the interface 26. The embedded on-chip switch manager90 also continuously self-checks the interface's functionality, e.g.,through a conventional watchdog routine 108, which interrupts impropersoftware execution. When a failure is detected (or when the self-testmode fails), the manager 90 switches to a safe mode, where commandexecution is inhibited and the navigation mode is disabled. Theinterface 26 displays a visual WARNING output, e.g., through a LED 110on the exterior panel 114, which is activated when the safe mode isentered. The interface remains in the safe mode until the user presses areset button 112 on the exterior of the interface 26 to continue.

D. The Operator Interface and GUI

In the illustrated embodiment, the graphics display device 38 of theoperator interface 36 supports SVGA or comparable display of graphicinformation by the GUI 46. The MPU 28 preferable has a SPECfp92benchmark of at least 25 to support rapid update of graphicalinformation on the GUI 46.

1. Start-Up

Upon boot-up of the MPU 28, the operating system 44 implements the GUI46. The GUI 46 displays an appropriate start-up logo and title image,followed by the START-UP screen 118, as shown in FIG. 4.

The START-UP screen 118 includes a column of icon push button controls120 to 134, which are labeled for each of the main operating modes orfunctions available to the MPU 28 for execution.

The illustrated embodiment provides these executable modes: RECORDINGPROTOCOLS (executing Application A1); PACING PROTOCOLS (executingApplication A2) VIRTUAL IMAGE NAVIGATION (executing Application A3);REAL IMAGE NAVIGATION (executing Application A4); TEST (executingApplication A5); PRINT (executing Application A6); and SERVICE(executing Application A7). Selected a button control 120 to 134 usingthe pointing device 42 or keyboard 40 (or touching the screen itself, ifa touch screen feature is provided), causes the operating system 44 todown load and implement the associated application on the MPU 28.

In the illustrated embodiment, the additional icon push button control134 labeled EVENT LOG is present on the start up screen 118. Thiscontrol 134, when selected, toggles on and off the display of an eventlog, which the Event Log Function F1 of the operating system 44continuously executes in the background. The Event Log Function F1records specified major events that occur during the course of a givenprocedure. More details about the Event Log Function F1 and the EVENTLOG toggle button 134 will be provided later.

As will be demonstrated later, each of these push button controls 120 to134 are displayed by the GUI 46 throughout a given operating session,regardless of what application is being executed. The push buttons 120and 132 for the executable modes are displayed in one color (e.g., grey)when not selected and a different color (e.g., green) when selected. Thelabel of the toggle push button 134 changes when selected.

In the illustrated embodiment, the operating system 44 itself is notavailable for general use by the operator, outside of the confines ofthe GUI 46. Access to the operating system 44 is restricted only toauthorized service personnel, through executing the password protectedSERVICE application A7, which will be described later.

Further details of the GUI 46 will be now described by selecting andexecuting the applications A1 to A7, as well as describing the executionof the functions F1 and F2.

2. Recording Protocols Application (A1)

The selection of the RECORDING PROTOCOLS push button 120 executes therecording protocols application (A1). The recording protocolsapplication A1 operates to define or configure electrode subgroups amongthe available electrodes 18 of the basket 58 and roving electrode 68, tofeed myocardial signal data from the subgroups to the input channels 116of the recorder 22.

The recording protocols application A1, when executed by the MPU 28,displays a first sub-window 136, as shown in FIG. 5. As can be seen inFIG. 5, all main mode and function push buttons 120 to 134 remaindisplayed on the right side of the window 136. The selected push button120 changes color when selected, while the other non-selected pushbuttons 122 to 134 remain displayed in their original state.

The first sub-window 136 allow the operator to define a RecordingConfiguration and a Recording Sequence. By selected the CONFIGURATIONcontrol tab 138 or the SEQUENCE control tab 140, the operator is able toswitch between the recording configuration window 136 (shown in FIG. 5)and a recording sequence window 142 (shown in FIG. 6).

a. Recording Configuration

The recording configuration window 136 displays an INPUT CHANNEL columnfield 144, a CATHETER TYPE column field 146, and an ELECTRODE columnfield 148. Information in these fields 144, 146, and 148 together definea currently valid Catheter Configuration, which is assigned by defaultor by the operator an identifier in a RECORD CONFIGURATION field 150.The recording configuration window 136 also displays an OUTPUT CHANNELfield 170, which assigns an output channel number to each electrode,which also becomes a component of the valid Catheter Configuration 150.

A catheter configuration can be saved as a file on the hard drive, forprocessing, editing, and retrieval. Various file management push buttoncontrols (CREATE 152, OPEN 154, SAVE 156, DELETE 158, and APPLY 160) areprovided for this purpose.

The INPUT CHANNEL field 144 identifies the input channels 116 of therecorder 22. The OUTPUT CHANNEL field 170 identifies the output channelassigned to each electrode. By default, the rows are indexed by INPUTCHANNEL in numeric or alpha-numeric order. Alternatively, the operatorcan index in channel output order, by selecting the SORT BY OUTPUTcontrol button 162. When selected, the SORT BY OUTPUT control buttonlabel toggles to SORT BY INPUT. The operator can always select indexingthe display either between recorder input channel or electrode outputchannel.

The operator can scroll using the control buttons 164, up and down theINPUT CHANNEL field 144 in conventional fashion. In the illustratedembodiment, the scrolling occurs in steps of sixteen, and information isupdated across all fields 144, 146, and 148 while scrolling.

For each INPUT CHANNEL, the recording protocols application A1 accepts aSTATUS field input 166, which indicates an non-operational state of thechannel (e.g., shorted or open). No input in the STATUS field 166 (i.e.,a blank field) indicates a good operational channel. The STATUS field166 receives input from the test application A5, or from self-testsconducted by the switch manager 90, as already described.

The INPUT CHANNEL field 144 can be edited by the operator, to associateavailable electrodes 18 or 68 with available recorder input channels116, as desired. As earlier explained, the operator can configure theINPUT CHANNELS into electrode subgroups, so a recorder 22 having alesser number of input channels than the number of electrodes cannevertheless be used to record and process signals obtained by themultiple electrode basket 58. For example, to configure sixty-four (64)electrode channels for input using a thirty-two (32) channel recorder,electrodes A1 to D8 define the first electrode subgroup, and E1 to H8define the next electrode group.

The OUTPUT CHANNEL field 170 can likewise be edited using a drop downmenu control 168 or by input from the keyboard 40. The OUTPUT CHANNELfield 170 accepts a numeric value from between 1 to 72.

The CATHETER TYPE field 146 contains an key word identifier, whichindicates the type of instrument carrying the electrodes 18 or 68, e.g.,whether it is a multiple electrode basket structure 58 (which isdesignated "Constellation" in FIG. 5, which in shorthand identifies aCONSTELLATION® Catheter sold by EP Technologies, Inc.), or a rovingelectrode 68 (for example, in shorthand, "Roving"), or some other typeof identifiable electrode configuration or shape typically used byelectrophysiologists (for example, in shorthand, "HIS, CS, HRA, RVA,"etc.).

The CATHETER TYPE column field 146 is editable, either by predefineddefault drop down menu control 168 or by input from the keyboard 40.Thereby, the operator can, in a single record configuration, associatewith the recorder input channels, several different types ofelectrode-carrying instruments, e.g., a multiple electrode basket 58 anda roving electrode 68, and others.

The ELECTRODE field 148 identifies each electrode 18 on the instrumentby the assigned numeric, alphabetic, or alpha-numeric code. As alreadyexplained, for the basket 58, the electrodes 18 are identified A1, B4,C6, etc., with the splines alphabetically identified (A, B, C, D, etc.),and the electrodes on each spline numerically identified from the distalto the proximal end of the spline (1, 2, 3, etc.). Instruments with asingle electrode or linear or curvilinear arrays of electrodes, like theroving electrode 58, can numerically identify electrodes in order fromdistal to proximal end of the instrument. The ELECTRODE column field 148is editable, either by predefined default drop down menu controls 168 orby input from the keyboard 40.

Selecting the file management control buttons (CREATE 152, OPEN 154,SAVE 156, DELETE 158), the operator can, respectively, establish a newrecord configuration, retrieve an existing record configuration as afile from the hard drive 32, save a new or edited record as a file tothe hard drive 32, or delete a record file from the hard drive 32. Byselecting the APPLY control button 160, the operator commands theinstrument interface 26 to be configured according to the currentrecording configuration.

b. Record Sequence

The record sequence window 142 (see FIG. 6) is displayed by selectingthe Sequence tab 140. The window 142 lists the recording sequences andthe order in which they are applied to the recorder 22 via theinstrument interface 26. The window 142 displays a CONFIGURATION columnfield 172, a SEQUENCE TYPE column field 174, a DURATION column field176, a #PULSES column field 178, and a #CYCLES column field 180. Eachrow of information in these fields 174 to 180 together define arecording protocol. The numeric order in which the protocols are listedcomprises a recording sequence. In the illustrated embodiment, thewindow 142 allows for a maximum of fourteen rows, that is, fourteendifferent recording protocols for each recording sequence.

Each recording protocol (row) in a given recording sequence is assigneda file name 182, either by default or by the operator for storage in thehard drive, with a ".rec" file identifier. The hard drive 32 can carrypre-determined recording protocols as .rec files, so that the operatorneed not be concerned about inputting the specifics of the recordingsequence. The file name 182 appears in the CONFIGURATION field 172. Therecording sequence, which lists the order of the protocols, is alsoassigned a file name 184 for storage in the hard drive 32, either bydefault or by the operator. This file name 184 appears in the editableRecord Sequence field.

Various file management push button controls (CREATE 186, OPEN 188, SAVE190, DELETE 192, ADD ROW 194, REMOVE 196, and APPLY 198) are providedfor establishing, retrieving, saving, removing, or otherwise editingrecording files retaining the protocols and recording sequencesconfigurations.

The SEQUENCE TYPE field 174 constitutes a control button, which togglesbetween Automatic mode and Manual mode. When set to Automatic mode, therecording application A1 applies the protocol row to the interface boxwithout requiring operator intervention, following the timing specifiedeither in the DURATION field 176 or #PULSES field 178, as will bedescribed later. When set to Manual mode, the recording application A1requires operator intervention before applying the protocol. In theillustrated embodiment, the operator intervenes by selecting the NEXTcontrol button 200 in the sequence window 142.

The DURATION field 176, the #PULSES field 178, and the #CYCLES field 180are each editable by input from the keyboard 40. The number inserted bythe operator in the DURATION field 176 specifies the number of secondsfor which the specified protocol is to be applied to the instrumentinterface 26. The number inserted by the operator in the #PULSES field178 specifies the number of pacing pulses for which the specifiedprotocol is to be applied to the instrument interface 26. The longer ofthe time period specified in the DURATION field 176 and #PULSES field178 controls the timing of the protocol applied to the instrumentinterface 26. The number inserted by the operator in the #CYCLES field180 specifies the number of cycles for which either the duration fieldvalue or pacing pulse field value controls the application of theprotocol to the instrument interface 26.

By selecting the file management control buttons (CREATE 186, OPEN 188,SAVE 190, DELETE 192), the operator can, respectively, establish a newrecord configuration, retrieve an existing record as a file from thehard drive 32, save a new or edited record as a file to the hard drive32, or delete a record file from the hard drive 32.

By selecting the ADD ROW control button 194, the operator adds a new rowof editable fields, in which the operator can add a new recordingprotocol for the recording sequence, which is assigned the nextsequential row number. Conversely, by selecting the REMOVE controlbottom 196, the operator can remove any highlighted protocol row.

By selecting the APPLY control button 198, the recording application A1commands the instrument interface 26 to be configured to carry out therecording sequence specified in the record sequence window 142. Therecording application A1 starts applying the sequencing row by row tothe instrument interface 26 in row order. The recording application A1displays a highlight 202 around the sequence row that is being currentlyapplied to the instrument interface 26.

By selecting the PAUSE control button 204, the recording application A1interrupts the sequencing. The control button label toggles to RESUME,which permits, when selected, the resumption of the sequencing, togglingthe label back to PAUSE.

By selecting the RESET control button 206, the recording application A1begins sequencing at the first listed row, regardless of the currentstatus of the sequence. The RESET control button 206 is active forselection only when the sequencing is paused or otherwise not beingapplied. Furthermore, changes to any editable field in the window 142are accepted only when the sequencing is paused or not being applied.

3. Pacing Protocols Application (A2)

The selection of the PACING PROTOCOLS push button 122 executes therecording protocols application A2. The pacing protocols application A2operates to define or configure the connectivity among the one or morepacing stimulators 20 and the electrodes connected via the instrumentinterface 26.

The pacing protocols application A2, when executed by the MPU 28,displays a first sub-window 208, as shown in FIG. 7. As can be seen inFIG. 7, the main mode or function push buttons 120 to 134 still remainin view on the right side of the window 208 in their original firstcolor, except the selected push button control 122, which changes colorwhen selected.

The first sub-window 208 allow the operator to define a PacingConfiguration and a Pacing Sequence. By selected the CONFIGURATIONcontrol tab 210 or the SEQUENCE control tab 212, the operator is able toswitch between the pacing configuration window 208 (shown in FIG. 7) anda pacing sequence window 214 (shown in FIG. 8). This GUI architectureparallels that of the recording application (A1), just described.

a. Pacing Configuration

The configuration window 208 displays an INPUT CHANNEL column field 216,a TERMINAL TYPE column field 218, an ELECTRODE column field 220, and aTERMINAL column field 222.

The information contained in the INPUT CHANNEL field 216, the TERMINALTYPE field 218, and the ELECTRODE field 220 corresponds to theinformation inputted by the operator on the current recordingconfiguration window 136 (FIG. 5) in the INPUT CHANNEL field 144,CATHETER TYPE field 146, and ELECTRODE field 148, respectively. Therecording configuration name in current recording configuration window136 (FIG. 5) (i.e., "constell") also appears in the PACE CONFIGURATIONfield 224 of the pacing configuration window 208. The pacing applicationA2 does not allow the operator to edit these fields 216, 218, and 220 inthe pacing configuration window 208, thereby maintaining conformitybetween the current recording configuration and the current pacingconfiguration. For each INPUT CHANNEL 216, the pacing protocolsapplication also displays a STATUS field input 226, which correspondswith the information in the STATUS field 166 in the current recordingconfiguration window 136 (FIG. 5). The operator can scroll using thecontrol buttons 228, up and down the rows in known fashion, which, inthe illustrated embodiment, is in steps of sixteen. Information acrossall fields is updated during scrolling.

The only editable field in the pacing configuration window 208 is theTERMINAL column field 222. The editable TERMINAL field 222 allows forselection of known electrode terminals by a drop down menu control 230.The drop down menu 230 contains the selections: "None", "1", "1+", "2-",and "2+". The pacing application A2 replaces a previously entered valueof the TERMINAL field 222 in a different row with "None" whenever theoperator selects the same terminal value in another row from the dropdown menu 230.

Selecting the file management control buttons SAVE 236 or DELETE 238,the operator can save a new or edited record as a file to the hard drive32, or delete a record file from the hard drive 32. The CREATE 232 andOPEN 234 control buttons are not active on the pacing configurationsheet, as a pacing configuration can be established or retrieved only inconjunction with the establishment or retrieval of a recordingconfiguration, through the recording applications A1.

By selecting the APPLY control button 240, the operator commands theinstrument interface 26 to be configured according to the current pacingconfiguration. When the APPLY button 240 has been selected, a DISCONNECTSTIMULATOR control button 242 appears in the window 208, preferably inred or another distinguishing color. The DISCONNECT STIMULATOR button242 allows the operator to immediately interrupt transmission of thepacing inputs to the hardware interface 26. The DISCONNECT STIMULATORcontrol button 242, once implemented, continues to be displayedthroughout the remainder of the operating session, regardless of whatapplication is implemented, unless selected to interrupt pacing.

b. Pacing Sequence

Selection of the Sequence tab 212 in the configuration window 208 opensthe pacing sequence window 214 shown in FIG. 8. The pacing sequencewindow 214 lists the pacing protocols and the order in which they areapplied to the stimulator 20 via the instrument interface 26.

The window 214 displays a CONFIGURATION column field 244, a SEQUENCETYPE field column 246, a DURATION column field 248, a #PULSES columnfield 250, and a #CYCLES column field 252. Each row of information inthese fields 244 to 252 together define a pacing protocol. The numericorder in which the protocols are listed comprises a pacing sequence. Inthe illustrated embodiment, the window 214 allows for a maximum offourteen rows, that is, fourteen different pacing protocols for eachpacing sequence.

Each pacing protocol (row) in a given pacing sequence is assigned a filename 254, either by default or by the operator for storage in the harddrive 32, with a ".pac" file identifier. The hard drive 32 can carrypre-determined pacing protocols as .pac files, so that the operator neednot be concern about inputting the specifics of the pacing sequence. Thefile name 254 appears in the CONFIGURATION field 244. The pacingsequence, listing the order of the protocols, is also assigned a filename 256 for storage in the hard drive 32, which is the same nameassigned to the current recording sequence (i.e. "test"), which appearsin the Pacing Sequence field 258.

The SEQUENCE TYPE field 246 constitutes a control button, which togglesbetween Automatic mode and Manual mode. When set to Automatic mode, thepacing application A2 applies the protocol row to the instrumentinterface 26 without requiring operator intervention, following thetiming specified either in the DURATION field 248 or #PULSES field 250,as will be described later. When set to Manual mode, the pacingapplication requires operator intervention before applying the protocol.In the illustrated embodiment, the operator intervenes by selecting theNEXT control button 260 in the sequence window 214.

The DURATION field 248, the #PULSES field 250, and the #CYCLES field 252are each editable by keyboard entry. The number inserted by the operatorin the DURATION field 248 specifies the number of seconds for which thespecified protocol is to be applied to the interface 26. The numberinserted by the operator in the #PULSES field 250 specifies the numberof pacing pulses for which the specified protocol is to be applied tothe interface 26. The longer of the time period specified in theDURATION field 248 and #PULSES field 250 controls the timing of theprotocol applied to the interface 26. The number inserted by theoperator in the #CYCLES field 252 specifies the number of cycles forwhich either the duration field value or pacing pulse field valuecontrols the application of the protocol to the interface 26.

Selecting the file management control buttons (CREATE 262, OPEN 264,SAVE 266, DELETE 268), the operator can, respectively, establish a newrecord configuration, retrieve an existing record as a file from thehard drive 32, save a new or edited record as a file to the hard drive32, or delete a record file from the hard drive 32. By selecting the ADDROW control button 270, the operator adds a new row of editable fields,in which the operator can add a new recording protocol of the recordingsequence, which is assigned the next sequential row number. By selectingthe REMOVE control button 272, the operator can remove any highlightedprotocol row.

By selecting the APPLY control button 274, the pacing application A2commands the instrument interface 26 to be configured to carry out thepacing sequence specified in the pacing sequence window 214. The pacingapplication A2 starts applying the sequencing row by row to theinstrument interface 26 in the order specified. The pacing applicationA2 applies a highlight 276 about the sequence row in the window 214 thatis being currently applied to the instrument interface 26.

When the APPLY button 274 has been selected, the DISCONNECT STIMULATORcontrol button 242 appears, preferably in red or another distinguishingcolor, to allow the operator to immediately interrupt transmission ofthe pacing inputs to the instrument interface. As before described, theDISCONNECT STIMULATOR control button 242, once implemented, continues tobe displayed throughout the remainder of the operating session,regardless of what application is implemented, unless selected.

By selecting the PAUSE control button 278, the pacing application A2temporarily interrupts the pacing sequence. The control button labeltoggles to RESUME, which permits, when selected, the resumption of thesequencing, toggling the label back to PAUSE.

By selecting the RESET control button 280, the recording applicationbegins sequencing at the first listed row, regardless of the currentpacing status. The RESET control button 280 is active for selection onlywhen the sequencing is paused or not otherwise being applied.Furthermore, changes to any editable field on the sheet is accepted onlywhen the sequencing is paused or not being applied.

4. Virtual Image Navigation Application (A3)

The selection of the VIRTUAL IMAGE NAVIGATION push button control 124runs the virtual navigation application A3. The navigation applicationA3, when executed by the MPU 28, displays a virtual navigation window282, as shown in FIG. 9. As can be seen in FIG. 9, the main applicationcontrol push buttons 120 to 134 still remain in view on the right sideof the navigation window 282 in their original first color, except theselected VIRTUAL IMAGE NAVIGATION push button control 124, which changescolor when selected.

a. Basket Display

The virtual image navigation application A3 generates in the window 282an idealized graphical image 284, which models the geometry of theparticular multiple electrode instrument 12 deployed in the body region.In the illustrated embodiment, the instrument 12 is thethree-dimensional basket 58, shown in FIG. 2, and the image 284 reflectsthis geometry modeled as a wire-frame image. By reference to this modelimage 284, the physician is able to visualize the location of eachelectrode and spline on the basket 58, as well as view the location ofthe roving electrode 68 relative to the basket image 284.

In the illustrated and preferred embodiment, the navigation applicationA3 provides split screen images (designated 284L and 284R) in a leftpanel 286 and a right panel 288.

To facilitate the creation of the images 284L and 284R, the electricalidentification code 100 of the basket 58, previously described, alsoidentifies the geometry and layout of electrodes on the basket 58. Thenavigation application A3 calls upon a library of idealized graphicalimages in hard drive storage 54, which reflect the different geometriesidentified by the code 100. Based upon the code 100, the navigationapplication A3 generates an idealized graphical image that correspondsto the geometry of the particular one in use. Alternatively, the toolbar296 can include a Basket Size push button 342, which, when selected,opens a dialog box from which the operator can select one basket sizefrom a listing of basket sizes.

In the illustrated embodiment (in which the array is a three dimensionalbasket 58), the model wire-frame image displays splines A to H in aselected first color, except for spline A, which is preferably displayedin a different color for reference and orientation purpose. By selectingthe toggle Show Splines control button 340, the left and right images284L and 284R display alphabetical spline labels A through H. Thecontrol button 340 toggles between Show Splines and Hide Splines, whichremoves the alphabetic labels.

In the left view, the X-axis of the image 284L is aligned by defaultalong the major head-to-foot axis of the patient, the Y-axis is alignedalong the shoulder-to-shoulder axis of the patient, and the Z-axis isaligned along the front to-back axis of the patient. The color of thesplines A to H is preferably displayed in different hues or shades toindicate their three-dimensional orientation along the Z-axis of thiscoordinate system, e.g., a bright shade when the spline appears in theforeground (when the Z value>0) and a dark shade when the spline appearsin the background (when the Z value<0). The idealized electrodes N canbe represented by small rectangles or nodes.

In the illustrated embodiment (see FIG. 10), whenever the operatorplaces the pointing device 42 over a given electrode N, a pop-up window292 displays the location of a selected electrode N by spline electrodedesignation (A1, B2, etc., as explained above). When a pace sequence hasbeen applied, the pop-up window 292 displays a menu 294, whichhighlights the pacing terminal type of the electrode (1+, 1-, 2+, 2-).If the pointing device 42 selects the roving electrode 68, the pop-upwindow 292 will identify it as "Roving."

As FIG. 9 shows, the left and right panels 286 and 288 make it possibleto simultaneously display the images 284L and 284R from differentidealized orientations. The navigation application A3 generates anOperational Screen Toolbar 296, which provides the physician with avariety of options to customize the idealized image 284L and 294R ineach panel 286 and 288. Using the Toolbar 296, or by entering associatedshort-cut command entries using the keyboard 40, the physician is ableto set up the desired images 284L and 284R in the left and right panels286 and 288.

In the illustrated embodiment (see FIG. 9), the Toolbar 296 includes anarray of Left View Control Buttons 298 for the image 284L displayed inthe left panel 286. The left panel 286 shows the image 284L from presetright or left anterior angles or preset right or left posterior obliqueangles. The Left View Control Buttons 298 allow the physician to chooseamong the preset orientations for the left image 284L, such as Left 45°or 30° (labeled respectively LAO45 and LAO30 in FIG. 9), Right 45° or30° (labeled respectively RAO45 and RAO30 in FIG. 9), orAnterior/Posterior (labeled AP in FIG. 9). An Edit Control field 316displays the currently selected preset orientation.

The Toolbar 296 also includes three sets of Orientation Control Buttons304(X), 304(Y), and 304(Z) to customize the viewing angle for the leftimage 284L. The buttons 304 (X,Y,Z), when selected, cause the left image284L to rotate about an idealized coordinate system located at center ofthe image 284L. Selection of the button 304 (X) rotates the image 284Lin either a left-to-right or right-to-left direction. Selection of thebutton 304(Y) rotates the image 284L in either a top-to-bottom orbottom-to-top direction. Selection of the button 304(Z) rotates theimage in either a clockwise or counterclockwise direction.Alternatively, or in combination with the Orientation Control buttons304 (X,Y,Z) the navigation application A3 can provide for rotation ofthe left image 284L by conventional "dragging" of the pointing device42.

The Orientation Angles for the present left image 284L are displayed inthe fields 306 (X), 306 (Y), and 306(Z), respectively, on the Toolbar296. The Toolbar 296 includes a RESET 312 button, which, when selected,inputs predefined default values as Orientation Angles in the fields306(X), 306(Y), and 306(Z), and the left image 284L is redrawnaccordingly.

The Edit Control field 316 includes a control button 318, whichactivates a drop down menu. The drop down menu lists the prescribedpreset orientations (LAO45, LAO30, RAO45, RAO30, and AP) for selection.The drop down menu also permits the physician to include on the listinga title identifying a custom orientation set up using the OrientationControl buttons 304 (X,Y,Z). The physician is thereby able to set up anduse custom orientations, along with the preset orientations.

The image 284R displayed in the right panel 288 is displayed from aselected orthogonal side angle relative to the left image 284L. Theorientation of the right image 284R is adjusted to reflect theadjustments in the orientation of the left image 284L. An array of RightView Control Buttons 300 allows the physician to select among presetorthogonal views for the right image 284R, e.g., as labeled in FIG. 9,Superior, Inferior, Left 90, and Right 90. The preset Superior view isoffset relative to the left image 284L 90 degrees about the Y-axis and180 about the X-axis. The preset Inferior view is offset relative to theleft image 284L minus 90 degrees about the Y-axis. The preset Left 90view is offset relative to the left image 284L 90 degrees about theX-axis. The preset Right 90 view is offset relative to the left image284L minus 90 degrees about the X-axis. A field 332 displays the name(e.g., Superior) of the selected preset view of the right image 284R.

In the illustrated embodiment, the navigation application A3 displaysorientation arrows 302 in the left panel 286 to assist the operator inestablishing the relationship between the left and right panel images284L and 284R. The orientation arrows 302 point at the left image 284Lalong the horizontal or vertical axis of the line of sight along whichthe right image 284R is viewed for display in the right panel 288. AsFIG. 9 also shows, the right panel 288 is also labeled Anterior (front)and Posterior (rear) to further help the physician orient the rightimage 284R. Other graphical clues, such as a bitmap human figure orsmall coordinate axes may be displayed to aid orientation.

In addition, the Toolbar 296 includes Fluor Angle Control buttons 320and associated Fluoro Angle field 322. When selected, the buttons 320rotate both the current left and right images 284L and 284R about theX-axis. The Fluoro Angle field 322 changes accordingly from zero to plusor minus 90 degrees. The buttons 320 allow the physician to match theorientation of the virtual images 284L and 284R with the orientation ofa real image of the basket 58 provided by the imaging device 72. Moredetails of this aspect of the system will be described later.

The Zoom Left push button 344 and the Zoom Right push button 346, whenselected, allow the operator to call up a full-screen image of,respectively, the left image 284L or the right image 284R. All functionsof the toolbar 296 remain function for the selected zoom image.

b. Binary Map Displays

In the illustrated embodiment, the Toolbar 296 (see FIG. 9) includescontrol buttons, which integrate for viewing in the display panels 286and 288 functions performed by the record protocols application A1 andthe pacing protocols application A2, previously described.

The SHOW PACE push button 290, when selected, opens in the right panel286 a modified version of the Pacing Configuration window 208 (shown infull form in FIG. 7). The modified version displayed upon selection ofthe SHOW PACE button 290 includes the Pace Configuration field 224, thescroll bar 228, the Input Channel Field 216, the Terminal field 222,along with the SAVE 236, DELETE 238, and APPLY 240 control buttons.

The NEXT REC push button 308 on the Toolbar 296 has the same function asthe Next control button 200 on the Record Sequence window 142 (see FIG.6), by advancing the record sequence to the next row when the currentrow is designated Manual in the Type field 174 of the Record Sequencewindow 142. Similarly, the NEXT PACE push button 338 on the Toolbar 296has the same function as the Next control button 260 on the PaceSequence window 214 (see FIG. 8), by advancing the pace sequence to thenext row when the current row is designated Manual in the Type field 246of the Pace Sequence window 214.

The toolbar 296 also includes a Binary Map push button 348. Whenselected (see FIG. 11), the Binary Map push button 348 opens a pushbutton selection menu 368 on the toolbar 296, listing CREATE MAP 350,SHOW MAPS 352, CLEAR MAPS 354, REMOVE MAP PTS 356, CLOSE 358, and MAPLEGENDS 360.

Selection of the CREATE MAP button 350, in turn, opens a sub menu 362 onthe toolbar 296, which lists the default selections for the binary maps,along with a CLOSE button 370. In the illustrated embodiment, the submenu 362 lists as map selections early activation, fractionation, goodpace map, concealed entrainment, and user defined. When one of thelisted choices is selected, the application A3 executes the desiredmapping function based upon input from the record and pace applicationsA1 and A2.

To facilitate interpretation of the selected binary map, the applicationA3 annotates the images 284L and 284R with graphical symbols, calledBinary Map Designators 364. The Designators identify by shaped andcolored symbols the recording electrodes, the pacing electrodes, theroving electrode 68, and regions of electrical activity that theselected map function seeks out. Selecting the MAP LEGENDS button 360(see FIG. 12) opens a sub menu 366, which lists the Binary MapDesignators 364 by type, shape, and color. Using the pointing device 42,the operator is able to select among the individual electrodes on thedisplayed images 284L and 284R, to designate (e.g., by clicking) whichelectrode is to serve as a pacing electrode or as a recording electrode.The operator is thereby able to control the pacing and recordingactivities using the images 284L and 284R on the display panels 286 and288.

The type of electrical activity highlighted by the Designators dependsupon the type of binary map selected. For example:

The early activation map identifies and marks with the appropriateBinary Map Designator the electrodes where early depolarization of theheart tissue has occurred (early depolarization is often an indicator ofabnormal heart tissue adjacent the electrode).

The fractionation map identifies and marks with the appropriate BinaryMap Designator the electrodes where the electrograms sensed by suchelectrodes appear fractionated or broken in appearance (again, theexistence of fractionated electrograms a particular electrode site isoften an indicator of abnormal cardiac tissue at that site).

The good pace map identifies and marks with the appropriate Binary MapDesignator the electrodes with a high pace mapping matching index. Thisindex reflects how many of the morphologies of 12-lead surfaceelectrocardiograms (ECG) acquired during non-induced arrhythmia matchthe morphologies of the same signals acquired during paced inducedarrhythmia from the particular electrode. If by pacing from a particularelectrode, a high number of the 12-lead ECG morphologies are similarduring non-induced and pace-induced arrhythmia then it is likely thatthe particular electrode 18 resides close to an arrhythmogenic focus.

The concealed entrainment map identifies and marks with the appropriateBinary Map Designator the electrodes where arrhythmia entrainment wasachieved (abnormal cardiac tissue often is located electrodes exhibitingconcealed entrainment).

The user defined map function enables the operator to place aoperator-specified Binary Map Designator on the displayed image 284L or284R. The operator may position the graphical symbol by pointing andclicking the pointing device 42 on the selected electrode or splineregion displayed on an image 284L or 284R. The operator can thus locateareas of cardiac tissue exhibiting certain preselected characteristics.

By selecting the SHOW MAPS button 352, the application A3 opens a dialogbox listing all existing binary maps that have been created. Using thepointing device 42, the operator can quickly select and switch among anyexisting binary map. The ability to chose among different mappingfunctions are of importance in identifying potential ablation sites.Frequently, abnormal cardiac tissue, which can be effectively treatedthrough ablation, often exhibits more than one abnormal characteristic.Such sites frequently appear on two or more of the early activation,fractionation and concealed entrainment maps. If the same electrode orgroups of electrodes appear on two or more of the early activation,fractionation, good pace map and concealed entrainment maps, a likelysite for ablation is particularly well indicated.

By selecting a Binary Map Designator 364 on one of the images 284L or284R, and then selecting the REMOVE MAP PTS button 356 on the selectionmenu 368 (see FIG. 11), the operator deletes the selected Designator364. By selecting the CLOSE button 370 on the selection sub menu 362,the application A3 dismisses the selection menu 362, deselects allDesignators 364, and returns control to the main menu 368.

Selecting the CLEAR MAPS button 354 deletes and clear all existingbinary maps. Selecting the CLOSE button 358 dismisses the section menu368 and returns control to the navigation window 282 (shown in FIG. 9).

c. Anatomic Features Displays

The toolbar 296 also includes a Features push button 372. When selected(see FIG. 13), the Features push button 372 opens a push buttonselection menu 374, with buttons for selecting Atrial Anatomic Features376 or Ventricular Anatomic Features 378. Selection of the button 376 or378 opens a dialog box 380 for the selected region. The selection box380 includes an anatomic features field 382 (listing e.g., the aorticvalve, the inferior vena cava, the superior vena cava, etc.), along withcontrol buttons labeled CLEAR ALL 384, REMOVE 386, and CLOSE 388. Theapplication A3 maintains an editable text file, from which the features382 in the field 382 are inputted.

Using the pointing device 42, the operator selects a feature from thefield 382, drags the selected feature to an image 284L or 284R, anddrops the selected feature at the appropriate location on the image 284Lor 284R. Having the relative locations of such anatomical structuresdisplayed relative to the images 284L and 284R helps the physician inguiding the roving electrode 68, and in mapping and treating the targetmyocardial tissue. The anatomic markers can be deleted as a group byclicking on the CLEAR ALL button 384, or can be selectively deleted byclicking the REMOVE button 386. Selection of the CLOSE button 388dismisses the features selection boxes 374 and 380 and returns controlto the navigation window 282 (shown in FIG. 9).

5. Image File Management

The navigation application A3 makes possible the establishment andprocessing of images files by providing Management Control Buttons,labeled OPEN 310 and SAVE 314, on the Toolbar 296 (see FIG. 9).

By selecting the SAVE button 314, the left image 284L, as currentlyconfigured in the left panel 286, is saved as an image file on the harddrive 32. Preferably, the image file is also saved as a record in thepatient data base 52, the details of which will be described later.

When the SAVE button 314 is selected, the navigation application A3reads the current values in the Orientation Angle fields 306(X), 306(Y),and 306(Z) (which can comprise a custom orientation) and computes thedata necessary to recreate the saved orientation and the otherprescribed preset orientations (LAO45, LAO30, RAO45, RAO30, and AP) forthe left image 284L. Before saving, the navigation application A3displays a dialog box asking the physician to designate which one of thepreset or custom views constitutes the primary selected view.

The OPEN control button 310 allows the physician to retrieve an existingimage record as a file from the hard drive 32 for further viewing andediting.

The navigation application A3 allows the physician to uniquely associatethe image 284L/R with a file record, so that the physician can quicklyrecall, process, edit, or switch among any previously saved image.

a. Navigation Data

The navigation application A3 also displays in the left and right panels286 and 288 an idealized image 324 of the roving electrode 68, showingits location relative to the idealized images 284L and 284R. Forexample, the roving electrode image 324 can appear as a square, withconsideration for a Z-axis shadowing effect, as previously described forthe splines. By selection of the toggle ROVING SITE button control 414,the display of the roving electrode image 324 can show a currentreal-time position for the image 324 (as FIG. 9 depicts), or in a trackview showing the path of movement for the image 324 over a period oftime.

There are various ways to generate position-indicating information totrack movement of the roving instrument relative to the basket 58.

b. Proximity sensing (Voltage Threshold Analysis)

In one embodiment (see FIG. 14), an electrical field F is establishedinside the body region S between an electrode 18 carried by the basket58 an indifferent electrode 326, coupled to an electrical reference 328.The electrode 68 carried by the roving instrument 14 senses voltageamplitudes in the field F. The magnitude of a given sensed voltageamplitude V_(SENSE) will vary according to location of the rovingelectrode 68 in the electric field F, and, in particular, to thedistance between the transmitting basket electrode 18 and the rovingelectrode 68.

The sensed voltage amplitude V_(SENSE) is compared to a threshold valueV_(THRESH). V_(THRESH) is selected based upon empirical data to reflecta voltage amplitude that occurs, given the electrical conditionsestablished, when a selected close-to-far transitional distance (e.g., 5mm) exists between transmitting and sensing electrodes. If the sensedvoltage amplitude V_(SENSE) is equal to or greater than the thresholdvalue V_(THRESH), the roving electrode 68 is deemed to be in a "closecondition" to the basket electrode 18 (e.g., closer than 5 mm).Otherwise, the roving electrode 68 is deemed to be in a "far condition"to the basket electrode 18.

Still referring to FIG. 14, the navigation application A3 can implementthis methodology by initialized the electrode nodes N on the GUI 46 at adesignated color or shade. The initialized color or shade for a givennode N constitutes a default visual signal to the physician, that theroving electrode 68 is at the "far condition" relative to the associatedbasket electrode 18.

In the navigation mode, the switch manager 90 of the ASIC 80periodically runs an algorithm from the embedded program 94, whichassesses V_(SENSE) for the roving electrode 68 relative to eachelectrode 18 on the basket 58. The manager 90 communicates the V_(SENSE)values associated with each basket electrode 18 to the navigationapplication A3 executed by the MPU 28. The navigation application A3compares each V_(SENSE) to a selected V_(THRESH). The navigationapplication A3 switches "ON" a given node N on the GUI 46, e.g., bychanging the designated color, shape, or shade or by flashing the nodeN, whenever the comparison indicates that the roving electrode 68 is ina "Close Condition" relative to the electrode 18 to which the node Ncorresponds.

In a preferred embodiment, as FIG. 15 shows, the physician is able toselect open a pop-up Sensitivity Adjustment Window 330. The Window 330allows the physician to alter the spacial sensitivity for theproximity-indicating output, i.e, by changing the threshold valueV_(THRESH) used by the navigation application A3.

It is possible for more than one node to be switched "ON" at the sametime, depending upon the orientation of the roving electrode 68 relativeto the basket electrodes 18. In the illustrated embodiment (see FIG.16), navigation application A3 interpolates the proximity-indicatingoutputs to switches "ON" a phantom node PN(2, 3) midway between twoelectrode nodes N2 and N3, each of which is in a "Close Condition" tothe roving electrode 68. As FIG. 16 also shows, if more two nodes, e.g.,N5, N6, N9, and N10 are ordered to be switched "ON" simultaneously, thenavigation application A3 interpolates by switching "ON" a phantom nodePN(5, 6, 9, 10) at the geometric center of the three or more electrodenodes N5, N6, N9, N10.

Further details of this manner of proximity sensing and display can befound in copending patent application Ser. No. 08/938,296, filed Sep.26, 1997, and entitled "Systems and Methods for GeneratingProximity-Indicating Output for Locating and Guiding Operative Elementswithin Interior Body Regions."

c. Spacial sensing (Electrical Field Analysis)

Alternatively (see FIG. 17), when in the navigation mode, the algorithmof the program 94 embedded with the ASIC 80 can direct the switchmanager 90 to generate an electrical field F from either the rovingelectrode 68 or at least one of the basket electrodes 30 (called the"transmitting electrode"). The electric field F will be characterized,in part, by the physical dimensions and spacing among basket electrodes18.

The program 94 also directs the switch manager 90 to condition eitherthe roving electrode 68 or at least one of the basket electrodes 18 tosense electrical potentials in the electric field, which will changebased upon the position of the roving electrode 68 relative to basketelectrodes 18. The sensed electrical potentials are communicated by theswitch manager 90 to the navigation application A3.

The navigation application A3 includes an embedded navigation algorithm454, which analyzes the spatial variations in the electrical potentialssensed within the field, in terms of, e.g., variations in phase, orvariations in amplitude, or both, or variations in impedances betweenthe transmitting and sensing electrodes. Knowing these spacialvariations in the electrical field, and knowing the physical dimensionsand spacing among basket electrodes 18 (which the identification code100 of the basket 58 provides, or which can otherwise be embedded asempirically derived mathematical coefficients and weighing factors inthe navigation algorithm 454), the navigation algorithm 454 generates alocation output 334. The location output 334 locates the rovingelectrode 68 within the space defined by the basket 58, in terms of itsposition relative to the position of the multiple basket electrodes 18.The navigation application A3 updates the display by the GUI 46 of themoving electrode image 324 based upon the location output 334.

Further details of the use of an electrical field to sense and locate amovable electrode within an interior body region can be found incopending patent application Ser. No. 08/320,301, filed Oct. 11, 1994,and entitled "Systems and Methods for Guiding Movable Electrode ElementsWithin Multiple Electrode Structures."

d. Spacial Sensing (Wave Form Analysis)

In another alternative embodiment (see FIG. 18), when in the navigationmode, the algorithm of the program 94 embedded with the ASIC 80 candirect the switch manager 90 to generate an electric wave form output Wfrom either the roving electrode 68 or at least one of the basketelectrodes 30. The shape of the electric wave form output W within thebasket 58 will be characterized, in part, by the physical dimensions andspacing among basket electrodes 18.

The program 94 also directs the switch manager 90 to condition theroving electrode 68 to periodically sense a local electric waveform. Themanager 90 communicates the sensed local wave form to the navigationapplication A3. The navigation application A3 includes a navigationalgorithm 454, which conducts a differential comparison of the waveformoutput and the sensed local waveform. Knowing the results of thedifferential waveform comparison, and knowing the physical dimensionsand spacing among basket electrodes 18 (which the identification code100 can provide or which can be otherwise embedded as empiricallyderived mathematical coefficients and weighing factors in the navigationalgorithm 454), the navigation algorithm 454 generates a location output336. The location output 336 expresses the position of the rovingelectrode 68 relative to the basket electrodes 18. The navigationapplication A3 updates the display the moving electrode image 324 on theGUI 46 based upon the location output 336.

Further details of the use of differential waveform analysis to senseand locate the position of a movable electrode within an interior bodyregion can be found in copending patent application Ser. No. 08/745,795,filed Nov. 8, 1996, and entitled "Systems and Methods for Locating andGuiding Operating Elements Within Interior Body Regions."

6. Marking Navigation Data

In a preferred embodiment, the toolbar 296 of the navigation window anINS MARKER control button 390 and a FIND SITE control button 392. Whenselected, the control buttons 390 or 392 make it possible to annotatethe displayed images 284L and 284R.

The INS MARKER control button 390, when selected, allows the operator toannotate either image 284L or 284R by adding an identifier or marker andan associated text comment to selected locations of the image 284L/R.When selected (see FIG. 19), the INS MARKER button 390 opens a MarkersControl Menu 394. The Markers Control Menu 394 includes push buttoncontrols labeled ADD MARKERS 396, MOVE MARKERS 398, DEL MARKERS 400, andCLOSE 402.

When the ADD MARKERS button 396 is selected, the application A3 enablesthe operator to operate the pointing device 42 to select a spot oneither image 284L or 284R and, by clicking, drop a shaped bitmap marker404 (shown in FIG. 19) on the image. The marker 404 includes anassociated number, which the application A3 assigns in numeric order asmarkers 404 are created. Once inserted in one image 204L or R, acorresponding marker 404 is automatically inserted in the other image.

As FIG. 19 shows, when the marker 404 is dropped into position on theimage, the application A3 opens a pop up comments window 406. The window406 includes an automatic time stamp 410 and an editable comments field408. The operator enters the desired comment into the comment window 406using the keyboard 40.

The markers 404 and comment windows 406 can be placed near electrodesnodes on either the foreground or background of the image 284L/R. Themarkers 404 and windows 406 mark selected locations that are significantor of interest, such as mapping sites, ablation sites, etc. Thephysician is thereby better able to remain coordinated and oriented withthe displayed image and, therefore, better able to interpret datarecovered by the basket 58.

When the marker control menu 394 is displayed, the application A3removes a selected marker 404 and associated comment window 406 when theDEL MARKER button 400 is selected. The MOVE MARKERS button 398, whenselected, allow the operator to drag and then drop a selected marker 404and associated comment window 406 to a different location on the image284L/R.

Selecting the CLOSE button 402 dismisses the marker control menu 394.The marker(s) 404 and comment window(s) 406 remain on the image 284L/R.Selecting the SAVE button 314 on the toolbar 296, as previouslydescribed, saves the image 284L/R together with all current markers 404and comment windows 406. Information resident on the entire graphicaldisplay, including model image 284L/R, markers 404, and associatedcomment windows 408 are saved as a data file records for storage,retrieval, or manipulation.

Selecting the FIND SITE button 392 opens a dialog box 410 (see FIG. 20),into which the operator enters an electrode coordinate (A1, B6, etc.).The navigation application A3 draws a flashing circle 412 about thecorresponding electrode node on both images 284L/R. The flashing circle412 remains on the image until another action is taken by the operator.

7. Real Image Navigation Application (A4)

The selection of the REAL IMAGE NAVIGATION push button control 126 runsthe real image navigation application A4. The application A4, whenexecuted by the MPU 28, displays a sub-window 416, as shown in FIG. 21,which displays in real-time the image 418 acquired by the imaging device72.

As can be seen in FIG. 21, the main application control push buttons 120to 134 still remain in view on the right side of the screen in theiroriginal first color, except the selected REAL IMAGE NAVIGATION pushbutton control 126, which changes color when selected.

The application allows the operator to process the image 418 in variousways to achieve different results.

a. Image comparison

The sub-window 416 of the application A4 displays the image 416 acquiredby the fluoroscope or other imaging device 72. This image 416 may beused in association with the virtual image navigation application A3 tohelp visualize the actual orientation of the basket 58 and rovingelectrode 68 in the body region.

The sub-window 416 includes a COMPARE control button 420. When selected,the visualize application switches to a new sub-window 422 (see FIG. 22,which displays in a left panel 424 the left panel image 284L of thevirtual navigation sub-window 282(generated by the application A3previously discussed) along with a right panel 426, in which thereal-time image 418 is displayed. The orientation control buttons 304(X,Y,Z) and 320 and associated numeric orientation angle fields 306 (X,Y, Z) and 322 present on the virtual image navigation screen 282 arealso displayed in the compare window 422. This presentation allows thephysician to compare the fluoroscopic or other independent image andmanipulate the GUI image 284L to more closely match the view of thereal-time image 418. The images 284L and R displayed on the virtualimage navigation screen 282 (see FIG. 9) are updates to reflect changesin orientation made using the compare screen 422.

In a preferred embodiment, the applications A3 and A4 permitpoint-and-drag control by the pointing device 42, to change the shape ofthe idealized image 284L on either navigation screen 282 or 422, to moreclosely match the shape of the image 418 as seen in the real-time imagepanel 426, or using an independent real time imaging system. The shapeof the idealized image 284L can be formed by dragging the pointingdevice 42, for example, to appear in a range of configurations fromspherical to a more elongated ellipsoid (when the image 284L depicts athree-dimensional basket 58, as shown in FIG. 22) or to appear in arange of curve radii, when the multiple electrode instrument 12comprises an elongated, curvilinear structure.

The compare windows 422 includes a SAVE control button 428. Whenselected, the SAVE button 428 saves the shape characteristic formed bythe physician in the compare window 422, along with other imageinformation, as already discussed. Once the idealized image 284L/R arecoordinated with the real image 418 through use of the compare window422, the physician can switch views of the idealized image 284L/Relectronically on the navigation screen 282, without furthermanipulating the real-time imaging device 72.

b. Image Processing

The sub-window 416 of the application A4 (see FIG. 21) also includesspecialized file management control buttons, labeled CREATE 430, OPEN432, SAVE 434, DELETE 436, and EDIT 438.

When the CREATE control button 430 is selected, the application A4freezes the real-time image 416 (or a prescribed sequence of videoimages 416) so that it can be grabbed for processing. When the EDITcontrol button 438 is selected, the operator can mark or annotate thegrabbed image or video image sequence with comments, in the same mannerpermitted by the INS MARKER button 390 of application A3, which has beenpreviously described (see FIG. 19).

When the SAVE control button 434 is selected, the grabbed image or videoimage sequences, with annotations, can be saved to the hard drive as adata base record file, preferably as part of the patient data base 52,which will be described in greater detail later.

Because real time image files are typically large (e.g. exceeding 50KB), various compression methods can be used to compress them and thus,save disk space. The compression can be lossy (i.e. when data areretrieved some information may be lost) or lossless (i.e. no data arelost upon retrieval). The compression ratios are higher for lossycompression. For fluoroscopy and ultrasound images, minor data loss isacceptable upon retrieval. In a preferred embodiment, real time videodata are stored into patient database 32 using optimal lossycompression. Once saved into the database 32, these images andannotations can be retrieved by selecting the OPEN button 432 for futureanalyses. The images and annotations, once opened, can be furtherannotated by selecting the EDIT button 438 (which recalls the MARKERSfunction), or can be removed from the data base 32 by selecting theDELETE button 436.

c. Image Analysis

The sub-window 416 of the application A4 (see FIG. 21) also includes anANALYZE IMAGE control button 440. When selected (see FIG. 23), theapplication A4 executes an embedded graphic analysis function 442. Thefunction .442 electronically process the video input signals 458 tomathematically generate digital three-dimensional basket coordinates 450and three-dimensional roving electrode coordinates 452. The digitalcoordinates 450 and 452 are communicated to the navigation processingalgorithm 454 of the application A3 to help construct the idealizedimage 284L/R displayed on the navigation screen 282.

In the illustrated embodiment (see FIG. 23), the basket electrodes 18and splines and the roving electrode 68 are visualized from twodifferent angles using a biplane fluoroscopy unit 444. The unit 444includes one fluoro arm 446, which captures a real AP(anterior-posterior) video image, and a second fluoro arm 448, whichcaptures either a real LAO90 (left-anterior-oblique) image or a realRAO90 (right-anterior-oblique) image of the basket 58. These images areprocessed through the interface 26 as the video signal inputs 458 to theapplication A4.

At the same time, the imbedded navigation algorithm 94 in the interface26 (previously described) receives from the basket electrodes 18 and theroving electrode 68 electrical position-indicating signals. Theinterface 26 conveys these as electrical signal inputs 456 to thenavigation processing algorithm 454 executed by the application A3. Aspreviously described, when the real image analysis function 442 is notenabled, the navigational outputs 334/336 of this algorithm 454 aredisplayed in graphical form on the image 284L/R.

When enabled by selection of the ANALYZE IMAGE control button 440, theimage analysis function 442, the analysis function 442 mathematicallycomputes, based up the video input signals 458, three-dimensionaldigital basket coordinates 450. The digital coordinates 450 are inputtedto the navigation processing algorithm 454 of the application A3. Theapplication A3 generates a basket image output 466 that takes the realimage basket coordinates 450 into account, thereby providing anidealized image 284L/R that more closely corresponds to the real image418.

As FIG. 23 also shows, when enabled, the analysis function 442 alsogenerates, based upon the real image of the roving electrode 68,three-dimensional roving digital coordinates 452. The application A3includes a comparator 464, which compares the three-dimensional digitalroving coordinates 452 to the location output (e.g., 334 or 336)generated by the navigation algorithm 454, as previously described (seeFIG. 17 or FIG. 18). The error output of the comparator 464 iscommunicated to an iterative calibration loop 460, which adjustsempirically initialized mathematical coefficients and weighing factorsassigned to the navigation algorithm 454 to minimize comparison errors.The analysis function 442 thereby provides a self-calibration featurefor navigation algorithm 454 of the application A3. The calibratedoutput 462 is used to construct the display of navigational informationon the navigation screen 282.

8. Test Application (A5)

The selection of the TEST push button control 128 runs the testapplication A5. The test application A5, when executed by the MPU 28,displays the test sub-window 468, as shown in FIG. 24. As can be seen inFIG. 24, the main control push buttons 120 to 134 continue to remain inview on the right side of the window 468 in their original first color,except the selected TEST push button control 128, which changes colorwhen selected.

The test application A5, when executed, conditions the switch manager 90to apply voltage among the various electrodes 18 and recorder inputchannels 116 (see FIG. 3)to verify the ability to operate according tothe configuration specified in the Record Configuration window 136(shown in FIG. 5). The test application A5 executes a short/open channeltest at each input channel pair specified by the operator on the testsub-window 468. The test application A5 displays the results of thetest. The test application A5 also allows the operator to set the localsystem time.

In the illustrated embodiment (see FIG. 24), the test sub-window 468includes a SHORT/OPEN TEST push button control 470, a 1 MV TEST pushbutton control 472, and a 5 MV TEST push button control 474. Thesub-window also includes a RESULTS data fields 476, 478, 480 alignedwith each test push button control 470, 472, and 474. The sub-window 468also includes an editable SET TIME data field 482 in HH:MM:SS format.

A START push button control 484 (to start a selected test), a STOP pushbutton control 486 (to stop a selected test), and a CLOSE push buttoncontrol 488 (to terminal all selected tests and close the testsub-window 468) are also displayed on the test sub-window 468.

a. Short/Open Test

In executing a Short/Open Test, the detection of shorted and openelectrodes can be performed either "exhaustively" or by specifyingparticular pairs of inputs and outputs. In the "exhaustive" test, allpossible combinations of input and output pins are tested. Althougheffective in finding all potential malfunctions, such a test takesconsiderable time. Alternatively, the test can be conducted only betweenspecified pairs of inputs and outputs. Operating speed is considerablyincreased using such a test protocol.

Upon selection of the SHORT/OPEN TEST button 470 and the START button484, the test application A5 configures the switch manager 90 to detectopen or shorted electrodes. In the illustrated embodiment, the ASIC 80includes a constant current source 490 (see FIG. 3), which can beselectively switched to each of the electrodes 18 and 68 coupled to theinterface 26.

Generally speaking, if the electrode 18/68 is outside the patient'sbody, a voltage condition above a specified high threshold will resultwhen the constant current source is coupled to an open electrode. Adetector 492 on the ASIC 80 (see FIG. 3) senses the occurrence of thehigh voltage. The detector 492 can also check whether the phase angle isgreater than a predetermined limit (e.g., 45°). If prescribed criteriaare met, the switch manager 90 returns an Open Electrode signal to thetest application A5. The test application generates an Open Electrodemessage in the associated RESULTS data field 476. The test applicationA5 also updates the STATUS field 166 in the recording configurationwindow 136 (see FIG. 5) and the STATUS field 226 in the pacingconfiguration window 208 (see FIG. 7) indicate an opened electrodecondition.

Generally speaking, if the electrode 18/68 is inside the patient's body,a low voltage condition below a specified low voltage threshold resultswhen the constant current source 490 is coupled to a shorted electrode.The detector 492 senses the low voltage condition. The detector 492 canalso check whether the phase angle meets various criteria. If prescribedcriteria are met, the switch manager 90 returns a Shorted Electrodesignal to the test application A5. The test application generates aShorted Electrode message in the associated RESULTS data field 476. Thetest application A5 also updates the STATUS field 166 in the recordingconfiguration window 136 (see FIG. 5) and the STATUS field 226 in thepacing configuration window 208 (see FIG. 7) indicate a shortedelectrode condition.

Further details regarding the Short/Open test criteria for the ASIC canbe found in copending patent application Ser. No. 08/770,971, filed Dec.20, 1996, and entitled "Unified Switching System forElectrophysiological Stimulation and Signal Recording and Analysis,"which is incorporated herein by reference.

The absence of an Open Electrode signal and a Shorted Electrode signalis interpreted by the test application A5 as an operational electrode.The test application A5 generates a operational electrode message in theassociated RESULTS data field 476. The absence of information in theSTATUS fields 166 and 226 in the recording configuration window 136 andthe pacing configuration window 208 likewise indicates an operationalelectrode condition.

b. High/Low Voltage Tests

Upon selection of the 1 MV TEST button 472 and the START button 484, thetest application A5 configures the switch manager 90 to output a low (1mV) electrical level for a set period of time to the electrodes.Likewise, upon selection of the 5 MV TEST button 474 and the STARTbutton 484, the test application A5 configures the switch manager 90 tooutput a high (5 mV) electrical level for a set period of time to theelectrodes.

To accommodate these test procedures, the ASIC 80 includes a highvoltage source 494 and a low voltage source 496 (see FIG. 3), which arecoupled to the outputs when so commanded by the test application A5. Thevoltages thus applied are sensed at the associated electrodes. Theabsence of the sensed voltages, or the sensing of different voltagevalues, indicates a faulty condition in the hardware interface 26. Thetest application A5 generates a an appropriate message in the associatedRESULTS data fields 478 or 480.

9. Print Application (A6)

The selection of the PRINT push button control 130 runs the printapplication A6. The print application A6, when executed by the MPU 28,displays the pint sub-window 498, as shown in FIG. 25. The main controlpush buttons 120 to 134 continue to remain in view on the right side ofthe print window 498 in their original first color, except the selectedPRINT push button control 130, which changes color when selected.

The print window 498 provides an array of push button controls, whichpermits the operator to select, by keyboard entry or pointing device 42,one or more screen displays to be printed on the printer. For example,the illustrated embodiment offers the buttons labeled for the followingprint selections: Record Configuration information 500, Record Sequenceinformation 502, Pace Configuration information 504, Pace Sequenceinformation 506, the Left Navigational Image 508, the Right NavigationalImage 510; the Real Image Freeze 512; all or selected data base items ofthe Patient Data Base 514(as will be described later).

When the PRINT control button 522 is selected, the print application A6compiles and formats the selected information for output to the printer34. The print application A6 also appends pre-designated patientinformation from the data base to the printout.

After a printing operation has begun, the print application A6 displaysstatus information in a PRINT STATUS field 524. A CANCEL PRINT buttoncontrol 526 allows the operator to cancel the current printingoperation. The CLOSE control button 528 dismisses the print window 498and returns control to the application being executed at the time thePRINT button 130 was selected.

10. Service Application (A7)

The selection of the SERVICE push button control 132 runs the serviceapplication A7. The service application A7, when executed by the MPU 28,displays the service sub-window 516, as shown in FIG. 26. The maincontrol push buttons 120 to 134 remain in view on the right side of thewindow 516 in their original first color, except the selected SERVICEpush button control 132, which changes color when selected.

The service window 516 displays a dialog box 518, which contains inputfields for the operator to enter a SERVICE IDENTIFICATION 520 and aPASSWORD 530. When the OKAY button 532 is selected, the serviceapplication A7 accepts the inputs in the fields 520 and 530 and comparesthem to known identification and password codes embedded in theapplication A7. When the inputs match the known codes, the serviceapplication A7 terminates the GUI 46 and returns control of the MPU 28to the underlying operating system 44. The service application A7provides access to the underlying operating system 44 and associatedhost computer functions only to authorized service personnel.

Selection of the CANCEL button 534 dismisses the service window 516 andreturns control to the application being executed at the time theSERVICE button 132 was selected.

11. The Event Log Function (F1)

The operating system includes an Event Log Function F1 (see FIG. 1),which retains in system memory a record of specified critical events asthey occur during the course of a given procedure. For example, in theillustrated embodiment, critical events can include: the selection ofthe APPLY control button 160 in the Recording Configuration window 136(FIG. 5); the selection of the APPLY control button 240 in the PacingConfiguration window 208 (FIG. 7); changes in the configuration of thepacing electrodes shown in the configuration control window 208 (FIG.7); the times at which the switch manager 90 applies a configured recordsequence or a configured pace configuration; and the selection of theDISCONNECT STIMULATOR button control 242.

In the illustrated embodiment, the Event Log Function F1 records thespecified events by time (read from the operating system 44) in theevent log 50 (see FIG. 1). The event log data base 50 indexes therecorded events according to patient information, the coordinates of theroving instrument, the recording configuration name, the pacingelectrodes, and comments (which identify the nature of the event).

The selection of the EVENT LOG control button 134 toggles display of thecontents of event log for the current session on and off. When thecontrol button is selected on, a pop-up window 536 is displayed on thenavigation screen 282 (see FIG. 27). The pop-up window 282 has datafield entries, provided from the event log data base 50, which arearranged under headers for Time 538, Roving Instrument Coordinates 540,Recording Configuration Name 542, Pacing Electrodes 544, and Comments546. When active, the operator can input additional information in theComment field 546. When the control button 134 is selected off, thepop-up window is not displayed, although the Event Log Function F1 stillcontinues to record events in the event log data file 50.

12. Patient Data Base Function (F2)

In the illustrated embodiment (see FIG. 1), the operating system 44includes a Patient Data Base function F2. The function F2 makes itpossible, during the course of a given procedure, to store, retrieve,and manipulate patient-specific and related procedure-specificinformation in a patient data base 52 resident on the hard drive 32. ThePatient Data Base function F2 creates data base items incorporatingpatient-specific and related procedure specific information, comprising,e.g., patient name and other identifying information, together withnavigation images 284L/R generated by the navigation application A3; thethreshold sensitivity set using the Sensitivity Adjustment window 330 inthe navigation application A3 (see FIG. 15); catheter configuration andrecording configuration and sequences generated by the recordingprotocols application A1; pacing configuration and sequences generatedby the pacing protocols application A2; physician's comments andannotations inserted by use of the Markers Control Menu 394 in thenavigation application A3 (see FIG. 19); anatomic features positionsinserted using the Features button 372 in the navigation application A3(see FIGS. 9 and 13); mapping information generated through use of thebinary map selection menu 368 by the navigation application A3 (seeFIGS. 11 and 12); contents of the Event Log 50; and fluoroscopy,ultrasound, or other medical images generated by the real imageapplication A4 (see FIG. 21).

The Patient Data Base function F2 compiles patient-specific andprocedure-specific information as disk files saved to the hard disk 32.The disk files in the data base 52 are organized in study subdirectoriesbased upon the patient's name. The data base items can also bemanipulated by the operator, e.g., selected data base files can beaccessed or opened upon command for editing, deletion, searching,listing, sorting, compiling, and printing.

a. Establishing Patient Data Base Information

The Patient Data Base function F2 can be implemented in various ways. Inthe illustrated embodiment, the Patient Data Base function F2 opens aPatient Data Window 548 (see FIG. 28) at the time that the Toolbar 296(previously described) is first generated by the navigation applicationA3 in the course of a given procedure, as this event occurs at thebeginning of a given study.

The Patient Data Window 548, when opened, requires the physician toenter data about the particular patient and procedure, to therebyestablish a new patient/study subdirectory in the data base 52, beforethe new study is allowed to proceed. Selecting the Cancel button 616dismisses the Data Window 548 without establishing a new patient/studysubdirectory, returning the operator to the navigation window 282 forthe current study.

To create a new patient/study subdirectory in the data base 52, andthereby enable the new study to proceed, the physician enters the nameof the patient and a numeric three digit sequence number in a Patientfield 550 of the Data Window 548. The Patient field 550 includes a dropdown menu control 572, listing existing patient names from which theoperator can select. Once the name is entered, the function F2 detectsexisting subdirectories for the same name and creates an addition studysubdirectory, or otherwise a new patient directory is established andthe new study subdirectory created. The function F2 assigns a name tothe new study in a Study Name field 554, with an associated time marker556. The patient three digit numeric sequence serves as a study nameextension.

The physician can enter in the Text field 558 of the Data Window 548additional information or comments regarding the patient, such as thepatient's ID number, age, etc., which the physician wants to save aspart of the patient/study record. The physician can also enterdiagnostic information, e.g., heart tissue pacing data; or therapeuticinformation, e.g., heart tissue ablation data; or identify the attendingphysician or staff personnel. The Data Window 548 includes an OpenButton 562, which recalls the most recent study record for the patient,and inserts information in the Text field 558 of the existing recordinto the Text field 558 of the new study record.

The physician clicks the New Study button 552 of the Data Window 548.The function F2 automatically saves the patient/study information to thenewly created subdirectory.

When the New Study button 552 is selected, the function F2 opens animage selection dialog box 564 (see FIG. 29). The dialog box 564 promptsthe physician to set the idealized image viewing angles. Selecting theReset button 568 starts the new study with default idealized image viewsin the left and right panels 286 and 288(which is the same function asthe Reset View button 312 on the Toolbar 296, as shown in FIG. 9). Oncethe new study is underway, the physician can proceed to customize thedefault left and right panel images 284L/R, as previously described.

Alternatively, selecting the Existing View button 570 in the imageselection box 564 starts the new study with the same markers, binarymaps, features, comments, sensitivity threshold, and views active in theimmediately preceding study. This option allows the physician to quicklyswitch among different diagnostic or therapeutic protocols (eachconstituting a "study") on the same patient using the same structure 58in the same heart chamber.

Once the view is selected, the dialog box 564 and Data Window 548 aredismissed, and control returns to the navigation window 282 (FIG. 9).The new study commences, with the selected image views displayed in thenavigation window 282.

During the new study, the physician can call upon all the features ofthe applications A1 to A7 and function F1 as already described. Forexample, the physician can set up binary maps, in the manner previouslydescribed (see FIG. 11 and 12), or mark anatomic features (see FIG. 13).The physician can set up markers 404 and comment windows 406 inassociation with the selected image views, as FIG. 19 shows. In thecomment windows 406, the physician can include further informationidentifying the procedure, diagnostic information, therapeuticinformation, or otherwise annotate the image 284L/R. By clicking theSAVE button 314 on the Toolbar 296 at desired times, the entiregraphical display, including the idealized image 284L/R, markers 406,and associated comment windows 406 are saved as a data file in thepatient/study subdirectory, uniquely associated with the particularstudy and particular patient for storage, retrieval, or manipulation.

b. Manipulating Patient Data Base Information

In the illustrated embodiment, selection of the Patient Data Base button514 in the print window 498 (FIG. 25) opens a patient record dialog box574 (see FIG. 30). The dialog box 574 includes a Patient Name field 576and a Study field 578, in which the operator can specify a particularsubdirectory. The fields 576 and 578 each include a menu control button580, which, when selected, opens a drop down menu listing patient namesand studies residing in the data base 32.

Selection of the Open button 582 opens a directory box 584 (see FIG.31), which list the files 618 contained in the specified subdirectory.The highlighted file can be opened for viewing (by selecting the Viewbutton 586); or printed (by selecting the Print button 588); or saved(by selecting the Save button 606).

Alternatively, selecting the Find button 590 in the window 576 (see FIG.30) opens a Find/Sort box 592 (see FIG. 32). The Find/Sort box 592provides access to special functions that compile, search, manipulated,or filter the records in the patient data base 52 in conventional ways,e.g., by use of a SEARCH DATA BASE control button 594 (which allowskey-word or file searching), a LIST DATA BASE control button 596 (whichlists data base files in established directory and subdirectory order),and a SORT DATA BASE 598 control button (which allows files be arranged,e.g., chronologically, by file type, etc.). The results of the requestedfunction are displayed for viewing in a Results field 598, which can beopened for viewing (by selecting the View button 604); or printed (byselecting the Print button 600); or saved (by selecting the Save button602). Selecting the Close button 620 dismisses the Find/Sort box 592 andreturns control to the Patient Records window 574 (see FIG. 30).Selecting the close button 622 in the Patient Records Window 574dismisses the window 574 and return control to the print selectionwindow 498 (as shown in FIG. 25).

As FIG. 1 shows, a communications link 610 allows patient recordinformation to be transmitted from the hard drive 32 to a central datastorage station 612. A network 614 of local or remote systems 10, 10(A),10(B), and 10(C), each having all or some of the features described forsystem 10, can be linked to the central data storage station 612, by anInternet-type network, or by an intranet-type network. The network 614,all linked to the central data storage station 612, allowspatient-specific data base records for many patients at one or moretreatment facilities to be maintained at a single location for storage,retrieval, or manipulation. In the illustrated embodiment (see FIG. 30),the patient record dialog box also includes an IMPORT control button608. When selected, the button 608 allows patient/study data base filesresiding on the station 612 to be up loaded into the patient data base32 resident on the system 10. Conversely, the various save functions inthe directory box 584 (see FIG. 31) or the Find/Sort box 592 (see FIG.32) can specify down loading patient/study data base files from the MPU28 to the central data storage station 612.

Various features of the invention are set forth in the following claims.

We claim:
 1. A system, comprising:an electrode structure which, in use,is deployed in contact with heart tissue; and an interface, theinterface includinga controller coupled to the electrode structureoperating to condition the electrode structure to perform a diagnosticor therapeutic procedure and to monitor events during the procedure, adisplay screen, and an interface manager coupled to the controller andthe display screen, the interface manager includinga first function togenerate a display comprising an image of the electrode structure atleast partially while performing the procedure, and a second function toannotate the image in response to events monitored by the controller,wherein the electrode structure and displayed image of the electrodestructure includes a plurality of electrodes and further including afunction to find an electrode on the display by entering a coordinate ofthe electrode.
 2. A system, comprising:an electrode structure which, inuse, is deployed in contact with heart tissue; and an interface, theinterface includinga controller coupled to the electrode structureoperating to condition the electrode structure to perform a diagnosticor therapeutic procedure and to monitor events during the procedure, adisplay screen, and an interface manager coupled to the controller andthe display screen, the interface manager includinga first function togenerate a display comprising an image of the electrode structure atleast partially while performing the procedure, and a second function toannotate the image in response to events monitored by the controller,wherein the second function includes a function to manually add anannotation to the image of the electrode structure on the display, theannotation selected from the group consisting of an identifier, amarker, and an associated text comment.
 3. A system according to claim 1or 2,wherein the first function includes an adjustment function tomanually alter the geometrical appearance of the electrode structureimage.
 4. A method for mapping myocardial tissue, comprising:deployingan electrode structure in contact with myocardial tissue; generating adisplay comprising an image of the electrode structure; causing theelectrode structure to pace myocardial tissue and recording pacedelectrical events in the myocardial tissue while the image is displayedfor viewing; and annotating the image in response to the pacedelectrical events which are recorded, wherein the electrode structureand displayed image of the electrode structure include a plurality ofelectrodes and further including finding an electrode on the display byentering a coordinate of the electrode.
 5. A method for mappingmyocardial tissue,deploying an electrode structure in contact withmyocardial tissue; generating a display comprising an image of theelectrode structure; causing the electrode structure to pace myocardialtissue and recording paced electrical events in the myocardial tissuewhile the image is displayed for viewing; annotating the image inresponse to the paced electrical events which are recorded; and manuallyadding an annotation to the image of the electrode structure on thedisplay, the annotation selected from the group consisting of anidentifier, a marker and an associated text comment.
 6. A method formapping myocardial tissue, comprising:deploying an electrode structurein contact with myocardial tissue; generating a display comprising animage of the electrode structure; causing the electrode structure topace myocardial tissue and recording paced electrical events in themyocardial tissue while the image is displayed for viewing; annotatingthe image in response to the paced electrical events which are recorded;and manually altering the geometrical appearance of the image.
 7. Aninterface for association with an electrode structure which, in use, isdeployed in contact with heart tissue to perform a diagnostic ortherapeutic procedure, the interface comprising:a display screen; and aninterface manager coupled to the display screen and including a firstfunction to generate a display comprising an image of the electrodestructure at least partially while performing the procedure, and asecond function to annotate the image to show an anatomic feature,wherein the electrode structure and displayed image of the electrodestructure includes a plurality of electrodes and further including afunction to find an electrode on the display by entering a coordinate ofthe electrode.
 8. An interface for association with an electrodestructure which, in use, is deployed in contact with heart tissue toperform a diagnostic or therapeutic procedure, the interfacecomprising:a display screen; and an interface manager coupled to thedisplay screen and including a first function to generate a displaycomprising an image of the electrode structure at least partially whileperforming the procedure, and a second function to annotate the image toshow an anatomic feature, wherein the second function includes afunction to manually add an annotation to the image of the electrodestructure on the display, the annotation selected from the groupconsisting of an identifier, a marker and an associated text comment. 9.An interface for association with an electrode structure which, in use,is deployed in contact with heart tissue to perform a diagnostic ortherapeutic procedure, the interface comprising:a display screen; and aninterface manager coupled to the display screen and including a firstfunction to generate a display comprising an image of the electrodestructure at least partially while performing the procedure, and asecond function to annotate the image to show an anatomic feature,wherein the first function includes an adjustment function to manuallyalter the geometric appearance of the image in response to operatorinput.
 10. A method for examining myocardial tissue,comprising:deploying an electrode structure in contact with myocardialtissue; generating a display comprising an image of the electrodestructure; annotating the image to show an anatomic feature; and causingthe electrode structure to conduct a diagnostic or therapeutic procedureaffecting myocardial tissue while the image is displayed for viewing,wherein the electrode structure and displayed image of the electrodestructure includes a plurality of electrodes and further includingfinding an electrode on the display by entering a coordinate of theelectrode.
 11. A method for examining myocardial tissue,comprising:deploying an electrode structure in contact with myocardialtissue; generating a display comprising an image of the electrodestructure; annotating the image to show an anatomic feature; causing theelectrode structure to conduct a diagnostic or therapeutic procedureaffecting myocardial tissue while the image is displayed for viewing;and manually adding an annotation to the image of the electrodestructure on the display, the annotation selected from the groupconsisting of an identifier, a marker and an associated text comment.12. A method for examining myocardial tissue, comprising:deploying anelectrode structure in contact with myocardial tissue; generating adisplay comprising an image of the electrode structure; annotating theimage to show an anatomic feature; causing the electrode structure toconduct a diagnostic or therapeutic procedure affecting myocardialtissue while the image is displayed for viewing; and manually alteringthe geometric appearance of the image.